Myrl Jeffcoat myrlj@jps.net

22 mars, 2005 10:27

Lack of Access to Foreign Studies

Numerous articles published in Japanese medical journals in the early 1960s documented cases of rheumatic disease, including a threefold increase in scleroderma (a fibrotic thickening of skin and vital organs) in women who had been injected many years earlier for breast enlargement. Unfortunately, due to the language difficulty and cultural lags, findings of these types—which often referred to the illness as “human adjuvant disease” (as noted in Dr. Kumagai and Shiokawa’s 1979 “Arthritis and Rheumatism” publications concerning four patients with scleroderma)—did not begin to appear in North America and British journals until the late 1970s (Additionally, among the 128 pieces of general medical implant literature on public file in the Dockets Management Department of Health and Human Services of the FDA as of May 1990, of those publications that discuss gel leakage or migration in any way, only about one dozen were published prior to 1980.)

Even when these findings were made available, however, some American physicians and the FDA attributed the problems to the use of inferior-quality silicone, paraffin, and other substances—not the medical-grade silicone used in American implants. While this was a legitimate criticism of the Japanese reports, it might also have been a convenient way for plastic surgeons to avoid taking a closer look into the lucrative and growing implant business. After all, the FDA relied on plastic surgeons to advise them of problems.  [page 18 – retyped from: “The Silicone Breast Implant Controversy – Frank Vasey, MD, and Josh Feldstein]